Transforaminal Prosthetic Spinal Disc Replacement and Methods Thereof

ABSTRACT

The present invention relates generally to a prosthetic spinal disc for replacing a damaged disc between two vertebrae of a spine and methods for inserting said discs. The present invention also relates to prosthetic spinal disc designs that are implanted using a transforaminal approach, methods thereof, and apparatus thereof.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/366,390 filed on Mar. 3, 2006 which is a continuation-in-part of U.S.application Ser. No. 11/318,438 filed on Dec. 28, 2005 which is acontinuation-in-part of U.S. application Ser. No. 11/246,149 filed onOct. 11, 2005. This application is also a continuation-in-part of U.S.application Ser. No. 10/909,210 filed on Jul. 30, 2004, which is acontinuation-in-part of U.S. application Ser. No. 10/827,642 filed onApr. 20, 2004, which claims the benefit of provisional application Ser.No. 60/491,271 filed on Jul. 31, 2003, all of which are incorporatedherein in their entireties by reference thereto.

FIELD OF THE INVENTION

The present invention relates to a prosthetic spinal disc for fully orpartially replacing a damaged disc between two vertebrae of a spine. Thepresent invention also relates to a method for implanting a prostheticspinal disc via transforaminal implantation.

BACKGROUND OF THE INVENTION

The vertebrate spine is the axis of the skeleton on which a substantialportion of the weight of the body is supported. In humans, the normalspine has seven cervical, twelve thoracic and five lumbar segments. Thelumbar spine sits upon the sacrum, which then attaches to the pelvis,and in turn is supported by the hip and leg bones. The bony vertebralbodies of the spine are separated by intervertebral discs, which act asjoints and allow known degrees of flexion, extension, lateral bending,and axial rotation.

The typical vertebra has a thick anterior bone mass called the vertebralbody, with a neural (vertebral) arch that arises from the posteriorsurface of the vertebral body. The centra of adjacent vertebrae aresupported by intervertebral discs. Each neural arch combines with theposterior surface of the vertebral body and encloses a vertebralforamen. The vertebral foramina of adjacent vertebrae are aligned toform a vertebral canal, through which the spinal sac, cord and nerverootlets pass. The portion of the neural arch which extends posteriorlyand acts to protect the spinal cord's posterior side is known as thelamina. Projecting from the posterior region of the neural arch is thespinous process.

The vertebrae also contains four articular processes that extend fromthe posterior region of the vertebra. There are two articular processeson the left side of the vertebra and two articular processes on theright side of the vertebra. Two of the four processes (one on the leftand one on the right) extend upwards from the top of the laminae and arereferred to as the superior articular processes. The other two processes(again one on the left and one on the right) extend downwards from thebottom of the laminae and are referred as the inferior articularprocesses. In a healthy spine the left and right superior articularprocesses of a vertebra form synovial joints with the left and rightinferior articular processes of the superior adjacent vertebra. Thesejoints are also referred to as facet joints. The facet joints aresynovial joints as the joints are encapsulated with connective tissueand lubricated by synovial fluid. The joint faces are also covered withsmooth cartilage, which acts to reduce friction and absorb shock.

The intervertebral disc primarily serves as a mechanical cushionpermitting controlled motion between vertebral segments of the axialskeleton. The normal disc is a unique, mixed structure, comprised ofthree component tissues: the nucleus pulpous (“nucleus”)* the annulusfibrosus (“annulus”) and two vertebral end plates. The two vertebral endplates are composed of thin cartilage overlying a thin layer of hard,cortical bone which attaches to the spongy, richly vascular, cancellousbone of the vertebral body. The end plates thus act to attach adjacentvertebrae to the disc: In other words, a transitional zone is created bythe end plates between the malleable disc and the bony vertebrae.

The annulus of the disc is a tough, outer fibrous ring which bindstogether adjacent vertebrae. The fibrous portion, which is much like alaminated automobile tire, measures about 10 to 15 millimeters in heightand about IS to 20 millimeters in thickness. The fibers of the annulusconsist of fifteen to twenty overlapping multiple plies, and areinserted into the superior and inferior vertebral bodies at roughly a 40degree angle in both directions. This configuration particularly resiststorsion, as about half of the angulated fibers will tighten when thevertebrae rotates in either direction, relative to each other. Thelaminated plies are less firmly attached to each other.

Immersed within the annulus is the nucleus. The healthy nucleus islargely a gellike substance having high water content, and like air in atire, serves to keep the annulus tight yet flexible. The nucleus-gelmoves slightly within the annulus when force is' exerted on the adjacentvertebrae while bending, lifting, and other motions.

The spinal disc may be displaced or damaged due to trauma, disease,degenerative defects, or wear over an extended period. A disc herniationoccurs when the annulus fibers are weakened or torn and the inner tissueof the nucleus becomes permanently bulged, distended, or extruded out ofits normal, internal annulus confines. The mass of a herniated or“slipped” nucleus tissue can compress a spinal nerve, resulting in legpain, loss of muscle control, or even paralysis. Alternatively, withdiscal degeneration, the nucleus loses its water binding ability anddeflates, as though the air had been let out of a tire. Subsequently,the height of the nucleus decreases causing the annulus to buckle inareas where the laminated plies are loosely bonded. As these overlappinglaminated plies of the annulus begin to buckle and separate, eithercircumferential or radial annular tears may occur, which may contributeto persistent or disabling back pain. Adjacent, ancillary spinal facetjoints will also be forced into an overriding position, which may createadditional back pain.

Whenever the nucleus tissue is herniated or removed by surgery, the discspace will narrow and may lose much of its normal stability. In manycases, to alleviate back pain from degenerated or herniated discs, thenucleus is removed and the two adjacent vertebrae are surgically fusedtogether. While this treatment alleviates the pain, all discal motion islost in the fused segment. Ultimately, this procedure places a greaterstress on the discs adjacent to the fused segment as they compensate forlack of motion, perhaps leading to premature degeneration of thoseadjacent discs.

As an alternative to vertebral fusion, various prosthetic discs havebeen developed. The first prosthetics embodied a wide variety of ideas,such as ball bearings, springs, metal spikes and other perceived aids.These prosthetics are all made to replace the entire intervertebral discspace and are large and rigid. Many of the current designs forprosthetic discs are large and inflexible. In addition, prosthetic discsizes and other parameters limit the approach a surgeon may take toimplant the devices.

For example, many of these devices require an anterior implantationapproach as the barriers presented by the lamina and, more importantly,the spinal cord and nerve rootlets during posterior or posterior lateralimplantation is difficult to avoid. Anterior implantation involvesnumerous risks during surgery. Various organs present physical obstaclesas the surgeon attempts to access the damaged disc area from the frontof the patient. After an incision into the patient's abdomen, thesurgeon must navigate around organs and carefully move them aside inorder to gain access to the spine. Additionally, the greater vessels arepresented during an anterior approach. These greater vessels (the aortaand vena cava) risk exposure and injury during surgery. One risk to thepatient from an anterior approach is that their organs may beinadvertently damaged during the procedure. Another risk to the patientfrom an anterior approach is that their greater vessels may be injuredduring surgery. These constraints and/or considerations have led tonovel prosthetic disc designs as disclosed in co-pending U.S. patentapplication Ser. No. 11/246,149, which is incorporated herein byreference in its entirety.

A posterior approach to intervertebral disc implantation avoids therisks of damaging body organs and vessels. Despite this advantage, aposterior approach raises other difficulties that have discouraged ituse. For instance, a posterior approach can introduce a risk of damagingthe spinal cord. For example, vertebral body geometry allows onlylimited access to the intervertebral discs and a posterior approachusually requires the retraction of the spinal cord to one side, or theother, or both during surgery. Because of the spinal chord's importancein the human body, reducing exposure of the spinal cord to injury duringsurgery is important. Thus, the key to successful posterior or posteriorlateral implantation is avoiding contact with the spinal cord, as wellas being able to place an implant through a limited area due to theshape of the vertebral bones. These constraints and/or considerationshave led to novel prosthetic disc designs as disclosed in co-pendingU.S. patent application Ser. No. 10/909,210, which is incorporatedherein by reference in its entirety.

Another known approach to the intervertebral space is the transforaminalapproach. This approach has been used in interbody lumbar fusionsurgeries and involves approaching the intervertebral space through theintervertebral foramina. This approach often requires the removal of onefacet joint on either the left or right side. After removal, the surgeongains access to the intervertebral space through the intervertebralforamina. One drawback to this method is that the removal of a facetjoint may lead to instability of the spine. Despite this drawback, inmany instances the transforaminal approach is favored in that there isreduced risk to the organs and greater vessels (as compared to theanterior approach) and reduced risk to the spinal cord (as to theposterior approach).

Accordingly, improved prosthetic disc designs tailored for use in atransforaminal approach to the intervertebral space are needed.

SUMMARY OF THE INVENTION

The present invention relates generally to a prosthetic spinal disc forreplacing a damaged disc between two vertebrae of a spine. Inparticular, the present invention encompasses a method for implantingthe prosthetic spinal disc via a transforaminal approach. The presentinvention further contemplates various instruments, aids, and otherdevices for implanting the various prosthetic disc designs. The presentinvention relates generally to a an intervertebral prosthetic disccomprising a first endplate having a first surface that engages a firstvertebral body and a second surface that is convex and partiallyspherical in shape. The prosthetic disc also has a second endplatehaving a first surface that engages a second vertebral body and a secondsurface that is concave and partially spherical in shape. The secondsurface of the endplates contact each other over an area and mayarticulate with respect to one another. The prosthetic disc isconfigured and designed for implantation through a transforaminalwindow, i.e. implanted at an oblique angle into the intervertebralspace.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more readily understood with reference to theembodiments thereof illustrated in the attached figures, in which:

FIG. 1 is an illustration of an embodiment of a prosthetic disc designof the present invention;

FIG. 2 is an illustration of a bottom endplate of a prosthetic discdesign of the present invention;

FIG. 3 is an illustration of a top endplate of a prosthetic disc designof the present invention;

FIG. 4 is an illustration of an embodiment of a prosthetic disc designof the present invention;

FIG. 5 is an illustration of an embodiment of a prosthetic disc designof the present invention;

FIG. 6 is an illustration of a keel of a prosthetic disc design of thepresent invention;

FIG. 7 is an illustration of a keel of a prosthetic disc design of thepresent invention;

FIG. 8 is a perspective view of another embodiment of the presentinvention;

FIG. 9 is a perspective view of an endplate of the embodiment of FIG. 8;

FIG. 10 is a perspective view of an endplate of the embodiment of FIG.8;

FIG. 11 is a perspective view of an endplate of the embodiment of FIG.8;

FIG. 12 is a perspective view of an endplate of the embodiment of FIG.8;

FIG. 13 is a perspective view of an embodiment of the present invention;

FIG. 14 is an exploded view of the embodiment of FIG. 13;

FIG. 15 is a cross sectional view of the embodiment of FIG. 13;

FIG. 16 is a perspective view of an embodiment of the present invention;

FIG. 17 is an exploded view of the embodiment of FIG. 16;

FIG. 18 is a cross sectional view of the embodiment of FIG. 16;

FIG. 19 is a perspective view of an embodiment of the present invention;

FIG. 20 is an exploded view of the embodiment of FIG. 19;

FIG. 21 is perspective view of an endplate of the embodiment of FIG. 20;

FIG. 22 is a cross sectional view of the embodiment of FIG. 20;

FIGS. 23-24 are perspective views of a representative vertebral body;

FIG. 25 is a perspective view of a separator according an embodiment ofthe present invention;

FIG. 26 is a perspective view of a separator according to an embodimentof the present invention;

FIGS. 27 and 27A is a perspective view of a trial according to anembodiment of the present invention;

FIG. 28 is a perspective view of a trial head according to an embodimentof the present invention;

FIG. 29 is a perspective view of a trial according to an embodiment ofthe present invention;

FIG. 30 is a perspective view of a trial according to an embodiment ofthe present invention;

FIGS. 31-32 is a perspective view of a trial and chisel according to anembodiment of the present invention;

FIGS. 33-34 are perspective views of an implant and implant holderaccording to an embodiment of the present invention;

FIGS. 35-36 are cross sectional views of an implant holder according toan embodiment of the present invention; and

FIGS. 37-38 are perspective views of an implant according to anembodiment of the present invention.

DETAILED DESCRIPTION

Embodiments of the invention will now be described. The followingdetailed description of the invention is not intended to be illustrativeof all embodiments. In describing embodiments of the present invention,specific terminology is employed for the sake of clarity. However, theinvention is not intended to be limited to the specific terminology soselected. It is to be understood that each specific element includes alltechnical equivalents that operate in a similar manner to accomplish asimilar purpose.

The present invention relates generally to a prosthetic spinal disc forreplacing a damaged disc between two vertebrae of a spine. The presentinvention also relates to a method for implanting a prosthetic spinaldisc via a transforaminal implantation. In particular, the presentinvention encompasses a method for implanting the prosthetic spinal discvia a transforaminal approach. The present invention furthercontemplates various instruments, aids, and other devices for implantingthe various prosthetic disc designs.

There are any number of considerations that must be factored intodesigns for prosthetic discs. In addition to size and configurationparameters that impact the implantation approach, the ultimate goal ofany prosthetic disc design is to treat patients with spine problems. Insome instances, the prosthetic disc design is used to restore propervertebral body spacing. In other instances, the prosthetic disc designis used to provide a means by which the vertebral bodies may moverelative to each other, either mimicking natural movement or providingincreased movement as compared to other treatments such asintervertebral fusion. Finally, any number of other considerations mayimpact the design of a prosthetic disc including, but not limited to,increasing stability of the spine and decreasing negative biomechanicaleffects on neighboring vertebrae due to degenerative disease.

The present invention contemplates the use of fixed and movinginstantaneous axis of rotation (IAR) and/or the center of rotation (COR)of one vertebral body with reference to another. The IAR and COR of ahealthy vertebral body with respect to another is constantly changing inalt planes because of pushing, pulling, and tethering of the segmentthrough its range of motion by the ligaments, annulus, muscles, facetsand other portions of the spine.

Past devices have attempted to mimic or partially mimic natural discmovement by including designs that provide for a moving IAR. Thesedesigns, however, typically have been achieved in the past at theexpense of a loss of stability of the device. Some examples ofprosthetic disc designs having a moving IAR are described in U.S. Pat.Nos. 4,759,766,5,401,269, and 6,414,551. Co-pending application Ser.Nos. 11/246,149, 10/909,210,10/827,642, and 60/491,271 describe improveddisc designs with variable IARs that mimic or partially mimic thenatural movement of a health disc.

During a transforaminal implantation the spine is subjected to increasedestabilization as a result of the removal of a facet joint.Additionally, disease or other considerations may lead a surgeon toprefer a prosthetic disc design that does not have a moving IAR.Accordingly, some embodiments of the present invention contemplateprosthetic discs with a fixed IAR. Another advantage of the present discdesign relates to the incorporation of stops and other mechanicalfeatures of the present invention that reduce the wear and stress on theremaining facet and other structural components of the spine. Generally,past prosthetic disc designs incorporating a ball and socket design withfixed IARs have been known to cause damage to facet joints due toanatomical interferences. The present invention contemplates discdesigns that reduce the tendency of fixed IAR prosthetic discs to impactstructural wear of the spine. Other embodiments of the present inventioncontemplate the use of prosthetic disc designs with a moving IAR,including but not limited to, the three component prosthetic discdesigns disclosed in co-pending application Ser. Nos. 11/246,149,10/909,210,10/827,642, and 60/491,271.

The materials used for different embodiments of the invention willdepend to some extent upon the type of surface contact being used aswell as the type and extent of wear that may result. Examples ofmaterials that may be used include, but are not limited to, polyethylene(or other elastomeric material) on metal, metal on metal, polyethyleneon polyethylene, or ceramic on ceramic. In some embodiments, metal onmetal is preferred because there is reduced wear of the prosthetic discand reduced debris over long-term use. Alternatively, in someembodiments, ceramic on ceramic may be used. In other embodiments, anynumber of various combinations of materials may be used.

Any prosthetic disc design must consider the type of and range ofmovements that it will allow. Naturally, the spine is capable of sixdegrees of freedom (1) compression, (2) distraction, (3) flexion, (4)extension, (5) lateral bending, (6) rotation, (7) linear translation.Disc designs may be unconstrained, critically constrained, orover-constrained. In an unconstrained device, the range of motion of aprosthetic disc is not limited by any mechanical limits of theprosthetic disc. In an under-constrained device, the prosthetic disc'srange of movement is limited to movements outside of the naturallyoccurring range of movement allowed or permitted by a natural healthydisc. In a critically constrained device, motion is allowed within thephysiologic range but limited beyond. An over-constrained device imposeslimits on the natural movement. Unconstrained designs of the presentinvention utilize the various components of the vertebral spine,including muscles, ligaments, facet joints, and other elements of thebody to limit the movement of the components of the prosthetic discs. Inconstrained designs, mechanical stops may be provided to limit the rangeof movement of the components of the prosthetic disc. The stops may bedesigned to limit one, two, or more of the various types of movementscapable by the prosthetic discs or the natural disc. The presentinvention contemplates prosthetic disc designs allowing for variousdegrees of movement, although in some instances, preferred embodimentsare constrained in the degree of freedom to limit structural wear of thespine. In alternate preferred embodiments, the design of prostheticdiscs of the present invention are constrained to limit the structuralwear on a remaining facet.

The articulating surfaces of the prosthetic discs of the presentinvention may be comprised of a convex and concave surface. In thisembodiment of the present invention, the prosthetic disc may allow foraxial rotation, radial rotation, extension, flexion, and bending of thespine. In some designs, the articulating surfaces may allow fortranslation of a vertebral segment relative to another. In theprosthetic disc embodiments of the present invention, the articulatingsurfaces of the prosthetic disc may be designed to allow for translationin one, two, or more than two directions.

Prosthetic discs of the present invention for use in a transforaminalapproach may be comprised of two components: a top piece (also referredto as a top endplate) and a bottom piece (also referred to as a bottomendplate). While for convenience's sake, the designs of the presentinvention will be described as top and bottom, or superior and inferior,it should be understood that any features associated with one endplateor piece could likewise be associated with the other endplate or piece.Similarly, while the articulating surfaces of the present invention maybe described in one particular manner, i.e. with the top piece made of aconvex surface and the bottom piece made of a matching concave surface,one in the art would understand that the type of the articulatingsurface of any particular endplate, whether the top or bottom, is notimportant.

Each endplate of the prosthetic disc of the present invention has aninner and outer surface. The outer surface of an endplate of theprosthetic disc is designed to interact or contact a vertebral bodysegment. The inner surface of an endplate is designed with anarticulating surface. The articulating surfaces of the present inventionare of a ball and socket design, which allow the inner surfaces of theendplates to articulate with respect to each other. The outer surface ofan endplate may be designed to conform to the surface of the vertebralbody to which the endplate attaches. Accordingly the outer surface mayhave a particular shape to coincide with the shape of a vertebral body.Alternatively, the outer surface of an endplate may be curved to conformto the contacting surface of a vertebral body. Alternatively, the outersurface of the endplate may have a keel, nails, spikes, or otherstructure to contact the vertebral body surface. Alternatively, theouter surface of the endplate may have bores through which fasteners maybe placed to anchor the endplate to the contacting vertebral body. Insome embodiment the outer surface of an endplate may contain one or moreof the features described above.

In addition to providing an endplate surface geometry or configurationthat may promote bony in-growth to hold the interfacing surfacestogether securely over the long term, these configurations also may helpprovide short term fixation of the endplate to the vertebral body. Forexample, a keel may have a wedge shape so that the width of a first endof the keel near the endplate is narrower than the width of the distalend. Once installed, the inverted wedge of the keel helps preventseparation of the endplate from the vertebral body at least until bonyin-growth can more securely hold the endplate in place.

To help accelerate and to further promote bony in-growth at theinterface between the vertebral body and the end plate, the end platemay be coated with an osteoconductive material and/or have a porous ormacrotexture surface. For example, the end plate may be treated with acoating that promotes bone growth. Examples of such coatings include,without limitation, hydroxyl appetite coatings, titanium plasma sprays,sintered beads, or titanium porous coatings.

FIG. 1 is an illustration of an embodiment of a prosthetic disc of thepresent invention. With reference to FIG. 1, the prosthetic disc has atop endplate 2 and a bottom endplate 4. Top endplate 2 has an outersurface 5 and an inner surface 6. Bottom endplate 4 has an outer surface8 and an inner surface 9. The prosthetic disc of FIG. 1 may be insertedinto the intervertebral space in a patient. When inserted, outer surface5 of top endplate 2 contacts a first vertebral body (not shown).Similarly, outer surface 8 of bottom endplate 4 contacts a secondvertebral body (not shown). As can be seen in FIG. 1, both the topendplate 2 and bottom endplate 4 have raised keels 10 and 12. As can beseen in FIG. 1, the top endplate 2 has a height Hi. Likewise, bottomendplate 4 has a height H₂. The exact height of the top endplate 2 andbottom endplate 4 may vary from design to design depending on any numberof considerations including for example the desired disc height in apatient or the amount of space available for implantation of the device.

In one embodiment of the present invention, the surgeon is provided akit with endplates of prosthetic disc designs. The kit may have, forexample, one bottom endplate with a set height and various top endplateswith different heights. Accordingly, the surgeon may select a topendplate for implantation with the bottom endplate such that the overallheight of the prosthetic disc after implantation restores the height ofa natural healthy disc. One advantage of providing a kit with more thanone top endplate of various heights, is that it allows the surgeon tocustomize the prosthetic disc with respect to height during surgery. Inaddition, the surgeon may also test fit various top endplates duringsurgery. If the disc height does not appear to be desirable, the surgeonmay simply substitute the top endplate for another one in the kit, andhence, make adjustments to the prosthetic disc during surgery. Ofcourse, one of skill in the art would understand that kits may beprovided where the top endplate has a fixed height and multiple bottomendplates with various heights are provided. Alternatively, the kit mayhave multiple top and bottom endplates which may have different heights.

With reference to FIG. 2, prosthetic disc designs of the presentinvention generally have endplates made with articulating surface. Withcontinuing reference to FIG. 1 and FIG. 2, bottom endplate 4 may have apartially spherical contact surface 21. Partially spherical contactsurface 21 may be convex and extend above inner surface 9 of bottomendplate 4. Partially spherical contact surface 21 may be dimensioned toprovide a sufficient area over which a top endplate (not shown) maycontact. As can be seen in FIG. 2, partially spherical contact surface21 is partially surrounded by a rim 23, which creates a transition zonebetween partially spherical contact surface 21 and inner surface 9 ofbottom endplate 4.

FIG. 2 further shows one part of a two-part mechanical stop according toone embodiment of the present invention. As seen if FIG. 2, partiallyspherical contact surface 21 of bottom endplate 4 has a channel 25extending through the convex partially spherical contact surface 21.Channel 25 has a bottom wall 26 and two side walls 27 and 28. Bottomwall 26 of channel 25 is substantially flat or parallel with interiorsurface 9 of bottom endplate 4. In alternative embodiments, however,bottom wall 26 of channel 25 may be convex or concave.

FIG. 3 is an illustration of a top endplate of a prosthetic discaccording to one embodiment of the present invention. Top endplate 2 hasa partially spherical contact surface 31 that is concave. Partiallyspherical contact surface 31 may be dimensioned to provide a sufficientarea over which a bottom endplate (not shown) may contact. Accordinglyand with reference to FIG. 2 and FIG. 3, partially spherical contactsurface 31 of top endplate 2 and partially spherical contact surface 21of bottom endplate 4 are substantially of similar dimension and shapesuch that when the prosthetic disc is assembled, contact surfaces 21 and31 mate over an area of each respective surface to create articulatingsurfaces. The articulating surfaces of this ball and socket type designimpart the degrees of movement between top endplate 2 and bottomendplate 4.

As seen in FIG. 3, partially spherical contact surface 31 is at leastpartially surrounded by rim 33. Rim 33 defines the outer circumferenceof partially spherical contact surface 31 and creates a transition zonebetween partially spherical contact surface 31 and inner surface 6 oftop endplate 2. As further seen in FIG. 3, partially spherical contactsurface 31 contains a raised portion or protrusion 35. Protrusion 35generally comprises the second part of a two-part mechanical stop.Protrusion 35 runs radially from one point along the outer circumferenceof partially spherical contact surface 31 to its opposite point throughthe center of partially spherical contact surface 31. Protrusion 35extends above partially spherical contact surface 31 and has two sidewalls 36 and 37 and a bottom wall 38. In FIG. 3, the protrusion is shownwith a concave bottom side wall although in alternative designs, bottomwall 38 may be convex or parallel to interior surface 6 of top endplate2.

FIG. 2 further shows one part of a two-part mechanical stop according toone embodiment of the present invention. As seen if FIG. 2, partiallyspherical contact surface 21 of bottom endplate 4 has a channel 25extending through the convex partially spherical contact surface 21.Channel 25 has a bottom wall 26 and two side walls 27 and 28. Bottomwall 26 of channel 25 is substantially flat or parallel with interiorsurface 9 of bottom endplate 4. In alternative embodiments, however,bottom wall 26 of channel 25 may be convex or concave.

FIG. 3 is an illustration of a top endplate of a prosthetic discaccording to one embodiment of the present invention. Top endplate 2 hasa partially spherical contact surface 31 that is concave. Partiallyspherical contact surface 31 may be dimensioned to provide a sufficientarea over which a bottom endplate (not shown) may contact. Accordinglyand with reference to FIG. 2 and FIG. 3, partially spherical contactsurface 31 of top endplate 2 and partially spherical contact surface 21of bottom endplate 4 are substantially of similar dimension and shapesuch that when the prosthetic disc is assembled, contact surfaces 21 and31 mate over an area of each respective surface to create articulatingsurfaces. The articulating surfaces of this ball and socket type designimpart the degrees of movement between top endplate 2 and bottomendplate 4.

As seen in FIG. 3, partially spherical contact surface 31 is at leastpartially surrounded by rim 33. Rim 33 defines the outer circumferenceof partially spherical contact surface 31 and creates a transition zonebetween partially spherical contact surface 31 and inner surface 6 oftop endplate 2. As further seen in FIG. 3, partially spherical contactsurface 31 contains a raised portion or protrusion 35. Protrusion 35generally comprises the second part of a two-part mechanical stop.Protrusion 35 runs radially from one point along the outer circumferenceof partially spherical contact surface 31 to its opposite point throughthe center of partially spherical contact surface 31. Protrusion 35extends above partially spherical contact surface 31 and has two sidewalls 36 and 37 and a bottom wall 38. In FIG. 3, the protrusion is shownwith a concave bottom side wall although in alternative designs, bottomwall 38 may be convex or parallel to interior surface 6 of top endplate2.

Whatever the particular design, the mechanical stops are intended toprovide constraints on the degrees of movement of the prosthetic disc,i.e., the degrees of movement allowed by the articulating surfaces ofthe contacting endplates. With continuing reference to FIGS. 2 and 3,channel 25 and protrusion 35 are designed to limit rotation of theprosthetic disc. In this embodiment of the present invention, channel 25has a width W_()t) Protrusion 35 is designed with a width, W₂, that isless than Wi. The particular widths, i.e. W| and W₂ may vary, althoughtheir dimensions will determine the amount of rotation allowed. Whenassembled, partially spherical contact surfaces 21 and 31 are mated orin contact and protrusion 35 lies or fits within channel 25. Uponrotation, side walls 36 and 37 of protrusion 35 may contact side walls27 and 28 of channel 25, hence limiting movement. As one of ordinaryskill in the art would understand, the respective widths of protrusion35 and channel 25 will determine the amount of rotation allowed.

Prosthetic disc designs of the present invention may further containadditional mechanical stops to control or limit movement in otherdegrees of freedom. For example and with continuing reference to FIGS. 2and 3, interior surfaces 31 and 21 of top and bottom endplates 2 and 4,respectively, may contain mechanical stops to limit lateral bending,flexion, and extension. As seen in FIGS. 2 and 3, rims 33 and 23 of topand bottom endplates 2 and 4, respectively, may be used to mechanicallylimit the lateral bending, flexion, and extension. In this embodiment,rims 33 and 23 of top and bottom endplates 2 and 4, respectively, aredimensioned and sized such that during flexion, extension, and/orlateral bending, rim 33 of the top endplate 2 and rim 23 of bottomendplate 4 may contact each other and prevent the articulating surfaces,i.e. partially spherical contact surface 31 of top endplate 2 andpartially spherical contact surface 21 of bottom endplate 4, fromfurther articulation.

In an alternate embodiment of the present invention, alternativemechanical stops are provided. With reference to FIG. 4, a prostheticdisc design is illustrated with mechanical stops to limit rotation ofthe respective articulating surfaces. As seen in FIG. 4, partiallyspherical contact surface 21 of bottom endplate 4 and partiallyspherical contact surface 31 of top endplate 2 are in contact and do notcontain any additional channels or protrusions as in previous designs.Instead, mechanical stops are formed on the interior surfaces 6 and 9 ofthe top endplate 2 and bottom endplate 4.

As seen in FIG. 4, interior surface 9 of bottom endplate 4 contains afirst part 43 of a two-part rotational stop. In this particularembodiment, the rotational stop is located on the posterior portion ofthe prosthetic disc. A first part 43 of the rotational stop is locatedon the interior surface 9 of lower endplate 4. First part 43 of therotational stop is made of a first and second protrusion 42 and 44,respectively, that extends from the interior surface 9 of bottomendplate 4. Protrusion 44 has five walls, four side walls 45, 46,47,48and one top wall 49. Similarly, protrusion 42 has five walls, four sidewalls 55, 56,57,58 and a top wall 59. In this particular embodiment ofthe prosthetic disc design, side walls 45 and 55 have angled surfaces asseen in FIG. 4. The second part of the rotational stop is located on theinterior surface 6 of top endplate 2. This part of the rotational stopis a protrusion that extends below the interior surface 6 of topendplate 2. Top endplate protrusion 63 has five walls, including fourside walls 65,67,68,69 and one bottom wall 70. In this particularembodiment of the prosthetic disc design, side walls 65 and 66 haveangled surfaces as seen in FIG. 4.

With continuing reference to FIG. 4, the first and second protrusions 42and 44 of bottom endplate 4 and protrusion 63 of top endplate 2 are notin contact when the prosthetic disc is assembled and in its neutralposition (shown in FIG. 4). During rotational movement, however,protrusion 63 of top endplate 2 will contact one of the first or secondprotrusions 42 or 44 of bottom endplate 4. For example, in one directionof rotation, side wall 65 of protrusion 63 of top endplate 2 willcontact side wall 45 of first protrusion 42 of bottom endplate 4, thus,limiting the movement or the articulating surfaces of the top and bottomendplates 2 and 4. As seen in FIG. 4, angled side walls 45, 55 and 65,67may cause the endplates to move as in flexion. Accordingly, this designprovides a softer or more cushioned rotational stop than would beencountered if the side walls were perpendicular to their respectiveinterior surfaces. In alternative embodiments, the angles formed betweenthe side walls and interior surfaces may be acute, in which case therotational stops might additionally serve to create the oppositemovement described above, namely, extension. As one of skill in the artwould understand, the placement of the rotational stops and angles ofthe side walls may be varied to achieve various results and degrees ofmovement.

Preferably, the height of first and second protrusions 42 and 44 ofbottom endplate 4 are sized, in conjunction with the height ofprotrusion 63 of top endplate 2, such that the upper walls 49 and 59 offirst and second protrusions 42 and 44 of bottom endplate 4 do notinterfere or contact interior surface 6 of upper endplate 2 duringflexion, extension, or lateral bending. Rather, rims 23 and 33 of upperendplate 2 and lower endplate 4 act to limit movement in thosedirections. Similarly, protrusion 63 of top endplate 2 is sized suchthat bottom wall 69 does not come into contact with interior surface 9of bottom endplate 4. The height of the rotational stop protrusions42,44,63 may be larger or smaller depending on the amount of flexion,extension, and lateral bending allowed by the rims on the interiorsurfaces of the top and bottom endplate as discussed above.Alternatively, in embodiments where rims are not provided as mechanicalstops for flexion, extension, and lateral bending, the heights of theprotrusions may be sized such that top walls 49 and 59 and bottom wall69 do come into contact with the interior surfaces of the top and bottomendplate, thus also serving as mechanical stops for flexion, extension,and lateral bending. Of course, one of skill in the art would understandthat to limit all three types of movement (in addition to the rotationallimitation) in a prosthetic disc design without rims, the design mayrequire an additional set of protrusions located at an anterior portionof the prosthetic disc.

FIG. 5 is an illustration of another embodiment of a prosthetic discdesign with an alternative mechanical stop design. As seen in FIG. 5,rotational stops may be provided located on the interior surface 6 ofupper endplate 2. In this embodiment, four cylindrical shaped pins71,72,73,74 are located on the four corners of interior surface 6 of topendplate 2. Bottom endplate is formed with holes 81,82,83,84 on interiorsurface 9 of bottom endplate 4 directly below cylindrical shaped pins71, 72, 73,74, respectively. In the prosthetic disc's neutral position,cylindrical pins 71-74 extend at least partly within the cavitiescreated by holes 81-84, respectively. Accordingly, during rotationalmovement the exterior surfaces of pins 71-74 contact the interiorsurfaces of holes 81-84 limiting movement. In some designs, holes 81-84extend entirely through bottom endplate 4. In alternative designs, holes81-84 may be blind holes, i.e. where holes 81-84 do not extend throughbottom endplate 4.

As would be understood by one of skill in the art, holes 81-84 are sizedin conjunction with pins 71-74, to provide for the freedom of movementdesired. Similarly, where holes 81-84 are blind holes, in some designsthe depth of holes 81-84 and the length of pins 71-74 may be dimensionedsuch that pins 71-74 contact the bottom portion of their respectiveholes 81-84 during flexion, extension, and/or lateral bending. Thisadditional stop mechanism may work in conjunction with the rim designpreviously described or may substitute the rims and be the primarymechanical stop to limit or constrain flexion, extension, and/or lateralbending. In alternative embodiments, only one pin and one hole may beprovided. In alternative embodiments, more than one hole and pin isprovided. Furthermore, it would be understood by one of skill in the artthat the pins and holes need not be cylindrical in shape but may alsotake various shapes yet still serve as rotational stops. Similarly, oneof skill in the art would understand that of the various mechanicalstops described, any number of variations and combinations may beemployed to limit movement of the articulating surfaces of theprosthetic disc designs.

In an embodiment of the present invention the prosthetic disc design isrotationally constrained and the endplates are allowed to rotate 1° ineither direction from its neutral position. In alternative embodimentsthe prosthetic disc design is rotationally constrained and the endplatesare allowed to rotate 10° or more in either direction from its neutralposition. In some embodiments of the present invention, the prostheticdisc design may be unconstrained in one, two, or more than two degreesof freedom. In some embodiments of the present invention, the prostheticdisc design may be constrained in one, two, or more than two degrees offreedom.

In one embodiment of the present invention, the upper and lower portionsof a disc assembly may be configured with a keel that can engage with orcontact a neighboring vertebral body. One advantage of providing a keelis that it may be used to guide the assembly into position duringinsertion into a treated area of the spine. For example, a channel orgroove may be cut out of a vertebral body to facilitate insertion of akeel. Then, a physician may insert the assembly into the vertebral bodyso that the keel slides in the groove or channel. The keel and grove maybe substantially linear or straight, or alternatively, may be curved orarched so that the assembly rotates and slides into position. The ridgesor keels and corresponding channels or grooves also may be straight orcurved to match the desired insertion path of the assembly. The groovesor channels formed in a vertebral body may help achieve the properorientation and distance of the assemblies and provide for a secureanchoring of the endplate or endplates.

The cross-sectional profile of the keel may have different shapes. Forinstance, the cross-sectional profile of the keel may have the shape ofa wedge, a truncated wedge, a rectangle, or a square. The channel orgroove may be cut to have a cross-sectional profile correspondingapproximately to the shape of the keel. One advantage of the keel havinga truncated wedge cross-section is that a similarly shaped channel orgroove may ensure that the keel engages with the bony surface. Thisconfiguration may also provide increased resistance to expulsion of thedisc assembly.

In one embodiment, the cross-section of a ridge or keel may betriangular or have a truncated triangular shape. For example, as shown,in FIG. 6, keel 90 is of a truncated triangular shape. The height ofkeel 90 may vary, but may be configured with sloped sides 92 and 94, asshown in FIG. 6, of about 5° from the longitudinal plane. The height ofkeel 90 may vary, but in general is designed to provide sufficientcontact area once inserted in the vertebral body to anchor endplate 95.The keel may be sized such that any groove or channel cut into thevertebral body to accommodate the keel does not substantially impact thestructural integrity of the vertebral body.

The use of one or more keels may also increase bone to implant surfacecontact, thereby decreasing the likelihood that the assembly will shiftor move about of position. In one embodiment, the increase in surfacecontact may be about 5% or more, which in another embodiment theincrease may be about 15% or more.

Over time, it is believed that the stability of the disc assembly in thetreated area will further increase as bone growth engages with outersurfaces of the disc assembly. To facilitate this growth and increasedstability, all or part of the surfaces of the disc assembly that engagesor otherwise contacts bone may be treated to promote bony in-growth. Forinstance, titanium plasma may be provided on the keel or other portionsof the assembly to provide a matrix for bone growth. In addition, thekeel may be configured with notches, slots, or openings formed along itslength. As bone grows into these openings, the disc assembly will becomemore securely anchored in place.

As a disc assembly is first inserted into a treated area, it may need tobe repositioned, rotated or otherwise moved. For instance, repositioningthe disc assembly may be needed so that the keel can properly engagewith the channel or groove. As shown in FIG. 7, keel 90 of endplate 95has an angled first leading edge 96. Additionally, endplate 95 may beconfigured with a second leading edge 97 that does not contain part ofkeel 90. Thus, in one embodiment the assembly can be partially insertedinto the treated area without keel 90 engaging with or contacting thevertebral body. In one embodiment, the length of second leading edge 97is from about 1 mm to about 10 mm, while in another embodiment secondleading edge 97 is from about 2 mm to about 5 mm. Alternatively, thelength of second leading edge 97 may be from about 1% to about 20% ofthe length of the endplate 95 on which it is disposed, or may be fromabout 2% to about 10%. The length of the endplate 95 may be determinedby measuring the longitudinal central axis of the portion or endplate onwhich second leading edge 97 is disposed.

In addition, referring again to FIG. 7, keel 90 may have first leadingedge 96 that is sloped or gradually increases in height. As seen in FIG.7, first leading edge 96 is sloped. Providing a ramped first leadingedge 96 may aid in aligning and inserting keel 90 into a groove orchannel formed in a vertebral body.

As mentioned previously, the keel of a disc assembly may be configuredto promote or permit bony in-growth that may help hold the disc assemblyin place more securely. FIG. 7 further illustrates an embodiment of keel90 having a plurality of slots or cuts 98 formed in it. In FIG. 7, slots98 may extend at an angle, such as from about 5° to about 40° off from avertical direction, and more preferably from about 10° to about 30°.Keel 90 may have two or more, or even three or more slots or cuts. Oneskilled in the art would appreciate that other configurations may alsobe used to promote bony in-growth that might help further secure thedisc assembly in place. For instance, the keel may have holes orapertures drilled into it, longitudinal or horizontal slots may beformed, and the sidewalls of the keel may be textured with one or moregrooves or channels that does not extend fully through the keel to theopposing sidewall.

In addition, the face of the keel that is first inserted into a grooveor channel may have a taper or chamfer. One potential advantage ofconfiguring a keel with a taper or chamfer on its face is that it mayassist in aligning the keel with the opening of the channel or groove.In addition, a chamfered or tapered face may help reduce drag forces andundesired cutting or gouging of the channel or groove as the keel ispushed toward its final position. As seen in FIG. 7, the face of keel 90is configured with a chamfer 99 to aid in the insertion of theprosthetic disc.

In an alternate embodiment of the present invention, differentprosthetic disc designs may be provided. With reference to FIG. 8, analternate embodiment of the present invention is provided. As seen inFIG. 8, a prosthetic disc 100 is provided having an upper endplate 110and lower endplate 120. Upper endplate 110 may be configured with a keel105, as discussed previously, to guide the endplate during implantationand increase contact area between the upper endplate 110 and the uppervertebral body (not shown). Similarly, lower endplate may be configuredwith a keel 115, to guide the endplate during implantation and increasethe contact area between lower endplate 120 and the lower vertebral body(not shown).

With continuing reference to FIG. 8, FIGS. 9 and 10 illustrate the lowerendplate. In FIG. 9, the lower endplate 120 is illustrated showing itssuperior surface 121, whereas in FIG. 10, the lower endplate isillustrated showing its inferior surface 123, i.e. the surface whichcontacts the lower vertebral body. As seen in FIG. 9, the lower endplateis configured with a partially spherical surface 125, which is concaveand provides a seating surface configured to contact with the convex,partially spherical surface of the upper endplate (described below).Disposed about concave partially spherical surface 125 of lower endplate120 is a partially conical rim that forms sidewalls 126 and 127 to theconcave partially spherical surface 125. Disposed about the perimeterrim of the concave, partially spherical surface 125, are two opposingwindows 128 and 129 formed out of, or interrupting, sidewalls 126 and127.

As seen in FIG. 9, window 129 leads to a cavity 131 that is has aninferior surface 133 and three sidewall surfaces 135, 137, and 139.While partially hidden in FIG. 9, one of skill in the art wouldunderstand that window 128 leads to cavity 132, which is similarlyformed with sidewall surfaces 134, 136, and 138. Cavities 131 and 132are recesses formed within lower endplate 120 that are configured tointeract with stops on the upper endplate, as described in more detailbelow.

With reference to FIG. 10, lower endplate 120 is shown having aninferior surface 123 upon which keel 140 is formed. The keel extendsgenerally the length of the lower endplate 123 and is disposed generallyalong the midline of lower endplate 120. Keel 120 may have notches 142formed within the keel body to provide areas into which bone may grow,and hence, provide a mechanism for increasing the attachment of lowerendplate 123 to the vertebral body. Similarly, keel 140 may be formedwith a leading edge 143 that is slanted towards the center of lowerendplate 120. This leading edge helps during insertion by providing afavorable contact surface as the prosthetic disc is inserted into thevertebral space.

With reference to FIGS. 11 and 12, upper endplate 110 is shown. In FIG.11, the upper endplate 110 is shown with a view of its superior surface111, whereas in FIG. 12, upper endplate 110 is shown with a view of itsinferior surface 112. As can be seen in FIG. 11, the upper endplate hasa keel 113, similarly positioned and configured as keel 140 of lowerendplate 120. One difference in this embodiment, however, is that keel113 of upper endplate 110 may have a window or cut-out 115 formed withinkeel 113. The cut-out 115 of keel 113 is a cavity disposed generally inthe center portion of keel 113. Cut-out 115 is preferably symmetricaland extends along keel 113 in equal directions from the center of theprosthetic disc. As a positioning feature, the cut-out is most effectiveif the center of cut-out 115 is the same as the center of upper endplate110 and prosthetic disc 100. In these instances, as one of skill in theart would understand, when the profile of prosthetic disc 100 is viewedin the medial-lateral plane, the center of cutout 115 corresponds to thecenter of the prosthetic disc. The positioning feature allows a surgeonto position the prosthetic disc within the intervertebral space,regardless of the angle at which the prosthetic disc was placed. Becausethe window remains visible in a profile view along a variety of angles,the center of the cut-out can be used to position the prosthetic discwithin the vertebral space. In this way, the cut-out provides a way toposition the prosthetic disc within the intervertebral space in aconsistent and simple manner, which is independent of the angle ofinsertion. This feature may also be used after implantation of theprosthetic disc during follow up visits to track the position of theprosthetic disc postoperatively.

With reference to FIG. 12, the inferior surface 112 of upper endplate110 is shown. As seen in FIG. 12, a partially spherical convex surface114 extends in the inferior direction from the inferior surface 112 ofupper endplate 110. Partially spherical convex surface 114 of upperendplate 110 is configured to engage with partially spherical concavesurface 125 of lower endplate 120 when the prosthetic disc is assembled.In this manner, the contacting surfaces, i.e. partially sphericalconcave surface 125 and partially spherical convex surface 114, mayarticulate with respect to each other. The articulating surfaces providethe relative rotation of the adjacent vertebral bodies, above and belowthe prosthetic disc. The partially spherical nature of the contactingsurfaces provides the fixed IAR and COR previously described above.

As can be further seen in FIG. 12, the inferior surface 112 of upperendplate 110 is configured with two stops 116,117 that extend downwardfrom the inferior surface 112 of upper endplate 110. In this embodiment,the stops are shaped as truncated cylinders, although in alternateembodiments the stops may take the form of any variety of shapes andconfigurations. As seen in FIG. 12, the stops are spaced apart from thepartially spherical convex surface 114 of upper endplate 110. As furtherseen in FIG. 8, when upper endplate 110 and lower endplate 120 areassembled, stops 116 and 117 of upper endplate 110 fit within cavities128 and 129 of lower endplate 120. While FIG. 8 is shown with theprosthetic disc in its neutral position, one of skill in the art wouldunderstand, that upon axial rotation of the endplates with respect toeach other, the stops would interact with the sidewalls of cavities131,132 and limit rotation of the endplates relative to each other. Asseen in FIG. 9, sidewall. 135 provides a surface against which stop 117abuts. As further seen in FIG. 9, sidewall 139 is not necessarilyconfigured to provide a contact surface for stop 117. This is so becausein this particular design, the remaining facet acts as a limitingmechanism for rotation in that direction. Accordingly, one of skill inthe art would understand that depending on the facet removed, thisembodiment may be designed in alternative configurations such that amechanical stop is integrated into the prosthetic disc design tocompensate for the removed facet, while relying on the remaining facetto act as a natural stop for rotation in the opposite direction.

As one of skill in the art would understand, the sizes of the cavitiesand stops may be varied to allow for the range of movement desired.Accordingly, in some instances it may be desirable to limit axialrotation to between about 1° to about 10°. In alternative embodimentsaxial rotation is limited to between about 3° to about 7°, or betweenabout 4° to about 6°, or to between about less than 1° to more than 5°.

In an alternate embodiment, prosthetic disc 150 has an upper endplate160 and lower endplate 170. With reference to FIG. 13, upper endplate isconfigured having a superior surface 161 and inferior surface 162.Superior surface 161 of upper endplate 160 is configured with a keel165, which may contain similar features as previously described.Inferior surface 162 of upper endplate 160 has a partially sphericalconcave surface 163. With continuing reference to FIG. 13, lowerendplate is configured with an inferior surface 171. Inferior surface171 of lower endplate 170 is configured with a keel 175, which also maycontain similar features as previously described. Superior surface 172of lower endplate 170 has a partially spherical concave surface 173.

With continuing reference to FIG. 13, FIG. 14 illustrates an explodedview of the embodiment of FIG. 13. As seen in FIG. 14, lower endplate170 is constructed from two pieces to from the lower endplate 170. Firstportion 176 comprises the inferior surface 171 having a keel 175 andsuperior surface 177 configured to receive a second portion 180. Secondportion 180 is a partially spherical wedge having a discreet thicknessand curvature. The curvature of partially spherical convex wedge 180corresponds to the partially spherical concave surface 163 of theinferior surface 162 of upper endplate 160, thus forming a partiallyspherical convex surface 181. While any number of methods may be used,one non-limiting method of attaching first portion 176 to second portion180 may be welding. In this example, the lower endplate 170 is formed ofa first portion 176 and second portion 180, wherein after attachment ofthe second portion 180 to the first portion 176 a cavity is formedbetween the first portion 176 and second portion 180 of lower endplate170. As seen in FIG. 14, second portion 180 further has two bore holes182, 183 disposed on its partially spherical convex surface 181.

Stops 185,186 may be used to limit the articulating between thepartially spherical concave surface 163 of upper endplate 160 and thepartially spherical convex surface 181 of second portion 180 of lowerendplate 170. Stops 182,183 have two portions, an attaching portion186,187 and a washer portion 188,189, respectively. These portions maybe integrally formed as one piece or may be formed as separate pieces.In an embodiment, attaching portion 186 is shaped as a cylindrical rodas seen in FIG. 14. Attaching portion 186 is configured to attach toupper endplate 160 on one end and attach to washer portion 188 on theother end. The attachment may be by any number of different meansincluding welding, fixation compounds, threaded attachments or others.When assembled, attaching portion 186 is fixedly attached to thepartially spherical concave surface 163 of upper endplate 160.Additionally, washer portion 188 is fixedly attached to attachingportion 186 after upper endplate 160 and lower endplate 170 have beenassembled, i.e., partially spherical concave surface 181 and partiallyspherical convex surface 163 are in contact. In this embodiment,attaching member 186 is attached to the upper endplate 160 such thatwhen the prosthetic disc is assembled, attaching members 186,187 passthrough bore holes 182,183 respectively. Washer members 188, 189 areconfigured to contact or abut the lower surface 190 of partiallyspherical wedge 180.

Washer members 188, 189 are also configured such that the upper surfaces191, 192 of washer members 188, 189 are sized such that washer members188, 189 will not pass through bore holes 182, 183. Accordingly as oneof ordinary skill in the art would understand, when assembled, partiallyspherical convex surface 181 and partially spherical concave surface 163may articulate with respect to each other but will be limited by theinteraction between the solid perimeters of bore holes 182,183 and theirinteraction with attaching portions 186, 187 of stops 186, 185respectively. Similarly, washer portions 188, 189 act to limitseparation of the upper endplate 160 and lower endplate 170.

As should be apparent from the foregoing description the size of theattaching members 186, 187 and/or the bore holes 182,183 may be adjustedto increase or decrease the amount of articulating that may beexperienced between the partially spherical surfaces 163,181.Additionally, one of ordinary skill in the art would understand that theconfiguration of bore holes 182,183 and/or attaching members 186,187 maydiffer, which would impact the degrees of freedom of the articulatingsurfaces 163,181. For example, where the bore holes are dimensioned tobe generally of elliptical shape, the articulating surfaces may rotatein greater amounts along the long access of the elliptical bore hole ascompared to the short axis. The present invention contemplates the useof differently sized bore holes and/or attaching members to createprosthetic discs with customized degrees of rotation along any number ofparameters, whether it be increased flexion/extension, increased lateralbending, etc.

With reference to FIG. 15, a cross sectional view of an assembledprosthetic disc of the embodiment of FIGS. 13 and 14 is shown. As seenin FIG. 15, stops 185,186 may be formed with a threaded end on stops185, 186. Similarly, upper endplate 160 may be formed with threadedcavities 193,194 into which stops 185,186 may be inserted. Stops 185,186 may be configured with engagement areas 195,196 to drive stops185,186 into threaded cavities 193, 194 of upper endplate 160. In thisparticular embodiment, engagement areas 195,196 take the form ofhexagonal heads for a hexagonal driver (not shown). As also seen in FIG.15, upper surfaces 197,198 of washers 188,189 of stops 185, 186 maycorrespond to the curvature of lower surface 190 of wedge 181 of lowerendplate 170. In FIG. 15, one may also see how keels 165, 175 are formedwith windows 166, 167 to aid positioning of the prosthetic disc asdescribed previously.

With reference to FIG. 16, an alternate embodiment of a prosthetic discis shown. Prosthetic disc 200 may be configured with upper endplate 210having a keel 205 with features similar to those described previously.Bottom endplate 220 may similarly be configured with a keel 206 hayingfeatures as described above.

Referring to FIG. 17, bottom endplate 220 may have a lower surface 221and upper surface 222. As seen in FIG. 17, upper surface 222 of bottomendplate 220 may be a partially spherical convex surface. Interposedbetween top endplate 210 and bottom endplate 220 are two intermediateportions 230,240. First intermediate portion 230 may have a generallycircular portion from which four arms 231,232,233,234 may extendtangentially along the latitudinal axis 235 of the prosthetic disc.First intermediate portion 230 may be formed with a bore hole 236disposed centrally as shown in FIG. 16. Arms 231-234 are designed toattached to lower endplate 220 as described in more detail below.

Second intermediate portion 240 may be generally circular in shape andmay have an upper surface 241 and lower surface 242. Lower surface 242of second intermediate member 240 is a partially spherical convexsurface and may be configured to engage upper surface 222 of lowerendplate 220. Lower surface 242 of second intermediate member 240 andupper surface 222 of lower endplate 200 may articulate with respect toeach other in a ball and joint fashion to allow movement of adjacentvertebra relative to each other. Second intermediate portion 240 mayalso have protruding members 243, 244 extending from the proximal anddistal ends of second intermediate portion 240, which are designed tointeract with first intermediate member 230 as described in more detailbelow. As seen in FIG. 17, second intermediate member 240 may have alinking member 245 positioned centrally on the upper surface 241 ofsecond intermediate member 240. In this particular design, post 245 isconfigured with a unique interlocking design at the superior end of post245. Respectively, upper endplate 210 may be configured with a receivingarea 247 designed to cooperate with the interlocking design of post 245.Accordingly, when assembled, second intermediate portion 240 is capableof being fixedly attached to upper endplate 210. In the embodimentillustrated in FIG. 17, the unique interlocking design of post 245 andthe receiving area 247 of upper endplate 210 not only provide for afixed connection, but also prevent the second intermediate member 240from rotating with respect to upper endplate 210. Accordingly, to theextent the upper endplate 210 is capable of moving when attached to avertebral body (not shown), second intermediate member 240 will movewith upper endplate 210. Also as seen in FIG. 17, a fastener 249 may beprovided to secure the connection between upper endplate 210 and secondintermediate member 240. In this case, the fastener is an exteriorlythreaded fastener that can partially pass through the receiving area 247of upper endplate 210 and engage an internally threaded blind holewithin post 245 of second intermediate portion 240. As seen in FIG. 18,lower surface 251 of upper endplate 210 may be configured with a collar252 that is configured to receive post 245 of second intermediateportion 240. Collar 252 adds stability to the connection between thesecond intermediate portion 240 and the upper endplate 210.

Returning to FIG. 16, first intermediate portion 230 is fixedly attachedto bottom endplate 220. As can be seen in FIG. 16, arm 231 is attachedto the upper surface 222 of bottom endplate 220. First intermediateportion 230 may be generally curved to correspond to the curvature ofarticulating surfaces of the prosthetic disc, i.e. upper surface 222 oflower endplate 220 and lower surface 242 of second intermediate portion240. First intermediate portion 230 may also be formed such that acavity 236 is created between parts of the aims and generally circularportion 237 as seen in FIG. 16. As one of ordinary skill in the artwould understand, a similar cavity 238 may be formed on the opposingside. Accordingly, cavities 236,238 provide space within which portionsof the second intermediate portion 240 may fit.

Referring to FIG. 18, a cross section view of the prosthetic disc ofFIG. 16 is shown. In this view, fastener 249 is inserted and connectsupper endplate 210 and second intermediate member 240. Firstintermediate member 230 is connected (connection not shown in crosssection) to lower endplate 210. When assembled, second intermediatemember 240 is captured by the first intermediate member 230. Even thoughsecond intermediate member 240 is captured, first intermediate member230 is formed such that first intermediate member 230 may stillarticulate relative to the partially spherical convex surface 222 oflower endplate 220. As can be seen by FIG. 18, however, the degree ofarticulation between the respective endplates may be limited by at leastthe interaction of post 245 and sidewall 253 of bore hole 236 of firstintermediate member 230. Accordingly, as one of ordinary skill in theart would understand, bore hole 236 and post 245 may be configured invarious sizes and dimensions to control the amount of articulatingbetween first intermediate portion 230 and lower endplate 220. Firstintermediate member 230 also prevents the separation of the upperendplate 210 and lower endplate 220 as the first intermediate member 230captures the second intermediate member 240, which is fixedly attachedto upper endplate 210.

Returning to FIG. 16, protruding members 256,258 are shown extendingfrom second intermediate member 240. Protruding members 256,258 mayextend from second intermediate member 240 at an angle, in the superiordirection. As seen in FIG. 16, protruding member 256 is configured suchthat upon axial rotation of the prosthetic disc, protruding member 256may contact sidewalls 257,258 of arms 232,233 of first intermediatemember 230. Accordingly, protruding members 256,258 may acts as stops orlimits on the degree of axial rotation of the prosthetic disc. As one ofordinary skill in the art would understand, protruding members 256,258and arms 231-234 may be sized and dimensioned to vary the degree ofaxial rotation permitted by the prosthetic disc.

Referring to FIG. 19, an alternate embodiment of a prosthetic disc ofthe present invention is shown having a top endplate 260 and bottomendplate 270. Top endplate 260 may have a keel 265 with features similarto those described above. Bottom endplate 270 may also have a keel 275with features similar to those described above. With reference to FIG.20, an exploded view of the present prosthetic disc embodiment isprovided. As seen in FIG. 20, the prosthetic disc has a top endplate 260and bottom endplate 270. Bottom endplate 270 has a lower surface 271 andupper surface 272. Upper surface 272 of bottom endplate 270 is apartially spherical convex surface. Attached to the upper surface 272 ofbottom endplate 270 are two side rails 273,274 that run the length oflower endplate 270 and are disposed at either side of the prostheticdisc as shown in FIGS. 19 and 20. Side rails 273,274 are each attachedat two different points on the upper surface 272 of lower endplate 270.Side rails 273,274 may be curved to match the curvature of partiallyspherical convex surface 272. As seen in FIG. 19, between attachmentpoints at the ends of rail 273, a window 276 is created. Window 276 hasan upper border 277 that is defined by curved rail 273 and a lowerborder 278 that is defined by the partially spherical convex surface 272of lower endplate 270. One of ordinary skill in the art would understandthat a similar window would be formed on the other side of theprosthetic disc.

Referring to FIG. 21, top endplate 260 is shown. Top endplate 260 hasthree portions connected to each other. Top portion 261 has an uppersurface 262 and lower surface 263, with keel 265 attached to the uppersurface 262. Extending from the lower surface 263 of top portion 261 ofupper endplate 260 is a middle portion 264 that extends generally alongan axis of the top portion 261 and extends in the inferior direction.Middle portion 264 is configured to support bottom portion 266 of topendplate 260. As seen in FIG. 21, bottom portion 266 is connected tomiddle portion 264, with the middle portion creating a link between topportion 261 and bottom portion 266. Bottom portion 266 has an uppersurface 267 and lower surface 268. Lower surface 268 of bottom portion266 of upper endplate 260 is a partially spherical concave surface.Partially spherical concave surface 268 generally corresponds topartially spherical convex surface 272 of lower endplate 270. As one ofordinary skill in the art would understand, upon assembly of theprosthetic disc of the present invention, partially spherical concavesurface 268 and partially spherical convex surface 272 may articulatewith respect to each other, allowing the upper endplate 260 and lowerendplate 270 to articulate as well. When inserted into theintervertebral space, the present design allows the vertebral bodies tomove or rotate in all planes with respect to each other.

With reference to FIG. 22, a cross section of the embodiment of FIG. 19is shown. In FIG. 22, the interaction between partially sphericalconcave surface 268 and partially spherical convex surface 272 is seen.Furthermore, FIG. 22 shows rails 273, 274 disposed between areas276,277, which are defined by the bottom surface 278 of top portion 261,side surfaces 279,280 of middle portion 264, and upper surface 281 ofbottom portion 266 of the top endplate 260. As one of ordinary skill inthe art would understand, rails 273, 274 serve to prevent the topendplate 260 and bottom endplate 270 from separating. This featureprovides a constrained design that adds stability and rigidity to theoverall prosthetic disc. Not only is the device constrained fromtension, i.e. separation along the longitudinal axis of the spine, butthe constrained design prevents sheer translation separation, i.e.separation of the components of the prosthetic disc as a result oflinear translation. Furthermore, the interaction between bottom portion266 and rails 273,274 as well as the interaction between rails 273,274and middle portion 264 serve to limit the range of rotation allowed bythe articulating surfaces 268,272. Accordingly, the prosthetic disc maybe designed to provide a range of rotation. As one or ordinary skill inthe art would understand, any number of changes may be made to the size,dimension, or shape of the rails, bottom portion, and/or middle portionto control the range of motion permitted by the prosthetic disc. In oneembodiment, the prosthetic disc is capable of axial rotation of betweenabout 1° and 3°. In alternative embodiments, the prosthetic disc iscapable of axial rotation of between about 1° and 5°. Alternatively, theprosthetic disc is capable of axial rotation of between 1° and 15°.

One consideration applicable to some embodiments of the presentinvention, include the desire to maintain the same degree of rotationsirrespective of disc position. This may be the case when the prostheticdisc is placed into the intervertebral space through a transforaminalapproach. As the prosthetic disc is seated within the vertebral space atan angle offset from either the anterior-posterior axis of the vertebralbodies and/or the medial-lateral axis of the vertebral bodies, it may bedesirable to provided uniform degrees of freedom between thearticulating surfaces of the prosthetic disc to accommodate naturalmovement in the anterior-posterior direction and medial-lateraldirection as well as provided for uniform degrees of freedom for coupledmotion. This freedom of movement must be designed in conjunction withthe shape of the prosthetic disc such that the shape of the disc, itsstops, and other structural features do not limit the degrees of freedomin one particular direction more than in others.

Another consideration in some of the embodiments of the presentinvention contemplate the design of prosthetic discs in shapes thatcomplement the implantation approach. For example, prosthetic discs of arectangular shape are particularly well configured for insertion at anoblique angle. Because the transforaminal window is small, rectangularshaped prosthetic discs provide a slim profile allowing easier insertionof the disc into the intervertebral space. Furthermore, these uniqueshapes also provide sufficient disc surface area to form stable contactswith the bone of the intervertebral space. Additionally, certain sizesprovide improved stability of the disc itself by providing sufficientarea for the articulating surface such that their respective movement isstable. All of these factors lead to disc designs with shapecharacteristics that make them particularly well suited for atransforaminal implantation, i.e. implantation at an oblique angle tothe anterior-posterior or medial-lateral approaches. It has been foundthat prosthetic discs with a Length to Width ratio of about 2 to 1 areparticularly well suited for transforaminal implantation in that saiddiscs fit within the transforaminal window and provide optimum contactareas for bone contact and articulating surface area contacts. Thus forexample, in one embodiment, the prosthetic disc has a length of 30 mmand a width of 15 mm. In alternative embodiments, the prosthetic dischas lengths between about 20 and 40 mm and widths of between about 8 and20 mm.

With respect to each embodiment herein described, it would be apparentto one of ordinary skill in the art that the particular directions andconfigurations of the various surfaces can be modified and interchanged.Accordingly, the upper endplate may be the lower endplate and viceversa. Similarly, stops may be formed on either or both endplates.Additionally, keels may be on both or none of the endplates. Moreover,the prosthetic discs of the current invention may additionally containany number of other features including for example, titanium sprays orother coatings or surface deposits that promote or help bonyingrowth/ongrowth. Similarly, the endplates themselves may be formed, inwhole or in part, of materials or contain materials that promote bonyingrowth/ongrowth. Also, the various embodiments disclosed herein arenot limited to construction out of any particular materials althoughmetal on metal designs are one variety contemplated.

As disclosed herein are methods for inserting a prosthetic disc assemblyinto the intervertebral space. In general, the method may involveremoval of a fact, preparation of the intervertebral space, creation ofone or more pathways, and insertion of a prosthetic disc via thetransforaminal approach. Specialized tools for performing said methodsare also disclosed.

Prior to insertion of the prosthetic disc, a surgeon must create aswindow into the disc space. When approaching the intervertebral spacefrom an oblique angle, a facet and number and other components of thebody, such as muscles and ligaments, must be accounted for. Accordingly,in an embodiment of the present invention a unilateral facetectomy isperformed.

With reference to FIG. 23, a vertebral body 300 is shown. Vertebral body300 may be from any part of the spine, although the methods herein areparticularly suited to lumbar areas of the spine. As seen in FIG. 23,only lower vertebral body 300 is shown. FIG. 23 also shows facets 302and 304. With reference to FIG. 24, facet 304 has been removed by asurgeon. As seen in FIG. 24, the entire facet has been removed to gainaccess to the intervertebral space. As further seen in FIG. 24, asurgeon may further prepare the bony surface of the vertebral body byscraping or cutting the surfaces of the bone. As one of skill in the artwould understand, a total facetectomy is not necessarily required.Depending on the size and configuration of the prosthetic disc beinginserted, a surgeon may perform a partial facetectomy. The amount of thefacet removed may be varied from one patient to the next, as the surgeonsimply needs a large enough window to insert the prosthetic discassembly.

In general, prior to insertion of the prosthetic disc, theintervertebral space may be further prepared to receive the prostheticdisc assembly. In one embodiment, a surgeon may perform a totaldiscectomy, in which substantially the entire disc between the twovertebra is removed. Alternatively, a surgeon may perform a partialdiscectomy, in which only a portion of the disc is removed. Partialdiscectomies typically leave a portion of the annulus of the disc intacton the anterior portion of the intervertebral disc space. The presentinvention is not limited to any particular type of discectomy, whethercomplete, partial or otherwise.

In an embodiment, another prepatory step in the process of inserting aprosthetic disc according to the present invention may includepreparation of the upper and lower surfaces of the vertebral bodies. Inthis step, a surgeon may scrape the upper and lower surfaces of thevertebral bodies. As seen in FIG. 24, lower surface 306 is shown havingbeen prepared to receive the prosthetic disc. Scraping the surfaces maycause some bleeding, which may improve the chances of bony growthinto/onto the inserted assemblies.

In another embodiment, the disc space is prepared by inserting varioustools to help loosen the muscles and ligaments that keep the disc spacetogether, referred collectively to as separator tools.

In an embodiment, a dilator may be provided. With reference to FIG. 25,a dilator is shown. As seen in FIG. 25, dilator 322 is similar to paddledistractor 308 except that the end of dilator 322 is configured as agenerally regular pyramid. Dilator 322 also has a handle 323 andelongated shaft 325. As one of skill in the art would understand, theshape and configuration of the dilator can aid the surgeon in preparingthe disc space by serving as a wedge as the dilator is inserted into theintervertebral space. As further seen in FIG. 25, demarcations 324 alongthe generally pyramid area 326 correspond to the thickness or width ofthe area at that point. Thus, a dilator with widths or thickness between5 mm and 20 mm may be used and the surgeon may distract theintervertebral space by a desired amount by inserting the dilator to theappropriate depth. In an embodiment of the present invention, a set ofdilators may be provided that correspond to a range of distractionsizes. For example, in one embodiment, a surgeon may be provided withthree dilators that contain a range of sizes of about 6-12 mm, 8-14 mm,and 10-16 mm.

As one of skill in the art would understand, handle 323 may bereleasably attachable such that a surgeon may use the same handle fordifferent dilators. As one of skill in the art would understand, a kitmay be provided that contains both dilators and paddle distractors. Inthis embodiment, a single handle may be used for both the differentdilators and different paddle distractors. Furthermore, a surgeon mayuse one type of separator during surgery or the other. Similarly, asurgeon may use both during the procedure.

In an alternate embodiment of the present invention, a paddle distractormay be used. With reference to FIG. 26, a paddle distractor 308 isprovided. Paddle distractor 308 may have a handle 310 that is attachedto an elongated shaft portion 312. As one of skill in the art wouldunderstand, handle 310 may be detached from shaft 312. At the end ofelongated shaft portion 312 paddle distractor 308 has an area shaped asa paddle 314, or an area that is wider than it is thick. The length ofpaddle area 314 may vary, although one of skill in the art wouldrecognize that said length would be sized appropriately so as to enterthe intervertebral space without interfering with surrounding tissue orother internal body parts. The shape of the paddle area allows a surgeonto insert the instrument in one direction, i.e. generally flat or sothat face 316 of paddle area 314 is generally parallel to the upper andlower surfaces of the upper and lower surfaces of the vertebral bodiesbetween which it is being inserted. Once inserted, a surgeon may rotatehandle 310 in turn causing paddle area 314 to rotate within thevertebral space. As sides 318 and 320 contact the upper and lowersurfaces of the vertebral bodies, the disc space is distracted and themuscles and ligaments are loosened. This helps prepare the disc spacefor insertion of the trial.

As one of skill in the art would understand, the size and shape of thepaddle distractor may vary and various sized instruments may be providedto accommodate different areas of the spine or distraction preferencesby the surgeon. Furthermore, distractors of various sizes may be used towithin the same space to distract the space in a stepwise fashion. Asthe handle is releasably attached, a single handle may be provided witha set of paddle areas such that a surgeon may select different sizesaccording to surgeon preferences. While any number of sizes may be used,in one embodiment a set of paddle areas with widths of 7 mm to 20 mm,with a separate paddle for each millimeter, is provided. In someembodiments, a paddle area for each possible trial is provided.

After preparing the intervertebral space the next step performedaccording to one embodiment, a surgeon determines the appropriate sizeof the assembly to use in the procedure as well as the desired positionof the assembly. The present invention contemplates tools and assembliesof various sizes to help a surgeon determine the appropriate prostheticdisc to implant. Trials, of various sizes, are commonly used in thistype of surgery to “test fit” items inserted into intervertebral spaces.For example, trials may have lengths between about 20 mm and 40 mm;heights between about 5 mm and 20 mm; and widths between about 8 mm and20 mm. In one embodiment of the present invention, trial sizeapproximately matches prosthetic disc size. In other embodiments, a kitmay be provided with trials, tools, and discs of various sizes.

With reference to FIG. 27, a trial 328 is shown. Trial 328 has a headportion 330, elongated shaft portion 332, and handle portion 334. Withreference to FIG. 27A, handle portion 334 is releasably attached toelongated shaft portion 332. As seen in FIG. 27A, elongated shaftportion has an engagement area 336, which engages with lever 338 ofhandle portion 334. As one of skill in the art would understand, anynumber of different mechanisms may be used to releasably attach handleportion 334 to elongated shaft portion 332.

With reference to FIG. 28, head portion 340 is shaped to approximate theheight and size of the prosthetic disc to be inserted. Head portion 340of trial 328 is also configured to allow a surgeon to precisely positionthe head portion with in the vertebral space. As the final position ofthe prosthetic disc assembly is dependent on or based on the positioningof the trial, a surgeon may desire to be able to position the trialwithin the vertebral space at a specific location. Accordingly in anembodiment of the present invention and as seen in FIG. 28, head portion340 has an elongated bore hole 342 running through head portion 340.This creates window 342 in head portion 340. As further seen in FIG. 28,a center post 344 is placed at the center of head portion 340.Accordingly as one of skill in the art would understand, thisconfiguration allows a surgeon to use imaging tools during surgery toposition head portion 340 of trial 328 in a desired position. Forexample, during surgery a surgeon may take radiological images of thearea during insertion of the trial into the intervertebral space alongthe medial lateral plane. The window and post configuration of headportion 340, thus allows the surgeon to accurately determine the centerof the trial head portion and allows the surgeon to make positioningadjustments. As one of skill in the art would understand, theconfiguration of the window, including its size and dimensions, allowfor the center post to be seen during imaging from a variety of angles,particularly considering that the approach to the intervertebral spaceis oblique. Furthermore, imaging along the anterior-posterior plane willsimilarly reveal the center of head portion 340 and allow a surgeon tomake positioning adjustments. As further seen, and discussed in moredetail below, the upper and lower surfaces of head portion 340 containchannels 346 and 348, which serve as keyed recesses for the chisel.

With reference to FIG. 29, after preparation of the vertebral bodies, asurgeon may insert trial 328 into the intervertebral space. As seen inFIG. 29, handle portion 334 of trial 328 may be configured with flatface 350. Accordingly, a surgeon may strike flat face 350 with anothertool to insert trial 328 to the desired depth. As discussed previously,a variety of positioning aids may be formed on the trial, and moreparticularly the head portion of the trial to aid the surgeon inpositioning the trial. Once trial 328 has been inserted and positionedby the surgeon, the surgeon may release handle portion 334 of trial 328.As seen in FIG. 30, this leaves head portion 330 and shaft portion 332of trial 328 inserted in the intervertebral space.

After removal of handle portion 334, a surgeon may then insert a chisel.With reference to FIG. 31, chisel 352 is an elongated hollow tubularshaft 354 with a blade portion 356 and end portion 358. Blade portionhas a first blade 360 and second blade 362 that are sized anddimensioned to cut paths into the upper and lower surfaces of theintervertebral space. Chisel 352 fits over shaft 332 of trial 328. Asone of skill in the art would understand, in an embodiment the shaft andchisel are shaped such that chisel 352 is keyed onto shaft 332.Accordingly, in such instances, shaft 332 may have a rectangular shapeand the interior elongated shaft 354 of chisel 352 will have asubstantially similar shape.

As seen in FIG. 31, blade portion 356 has two individual blades 360 and362 connected to shaft 354 of chisel 352. Blades 360 and 362 are shapedand dimensioned to cut pathways into the upper and lower vertebralbodies to receive the keels of the prosthetic disc assembly beinginserted. As further seen in FIG. 31, head portion 330 of trial 328 maybe formed with an upper channel 348 and lower channel 346 in uppersurface 364 and lower surface 366, respectively, of the head portion330. Upper and lower channels 348 and 346 are configured to receiveblades 360 and 362. In this fashion, the blades are directed along aparticular path and the location of the pathways formed in the upper andlower surfaces of the intervertebral space are determined by theposition of the trial head, which in turn is controlled by the surgeon.

As seen in FIG. 31, end portion 358 of chisel 352 is configured with acircular portion 368, which is configured for a surgeon to grasp. Withreference to FIG. 32, end portion 358 is also hollow. End portion 358may be configured with a flat face 370, which provides a strike surfacefor a surgeon. Accordingly, a surgeon may use an instrument to strikeflat face 370 of chisel 352 and drive the chisel into the intervertebralspace. In an embodiment of the invention, the overall length of chisel352 is configured such that upon full insertion of chisel 352 over trial328 and into the intervertebral space, end portion 372 of shaft 354 isaligned with flat face 370. Thus, the two surfaces act as a stop orreference that the surgeon may use as an indication that the chisel hasbeen fully inserted. In conjunction with this feature, the shaft mayalso be configured to provide a stop. As seen in FIG. 32, end 374 ofchisel 352 is configured to abut or contact head portion 330 of trial328. This contact may further act as a stop or indication that thechisel has been fully inserted into the intervertebral space.

As seen in FIG. 32, the chisel has been fully inserted into theintervertebral space. Accordingly, pathways have been cut in both theupper and lower surfaces of the intervertebral space. With reference toFIG. 33, chisel 352 and trial 328 have been removed. As seen in FIG. 33,pathway 376 is shown cut into the lower vertebral body. For the sake ofclarity, the upper vertebral body is not shown although one of skill inthe art would understand that a similar pathway is cut by the chisel inthe lower surface of the upper vertebral body.

After removal of the chisel and trial, a surgeon may then insert theprosthetic disc assembly. As seen in FIG. 33, prosthetic disc assemblyis releasably attached to implant holder 378. A surgeon may then useimplant holder to insert prosthetic disc 380 into the intervertebralspace. As one of skill in the art would understand, keels 382,384 arealigned with the pathways cut into the upper and lower surfaces of theintervertebral space. Once aligned, a surgeon may then drive theprosthetic disc into the intervertebral space. Implant holder may bedesigned with flat face 386 to provide the surgeon with a strike surfaceto help drive the implant into the intervertebral space.

With reference to FIG. 34, implant 380 may be released from implantholder 378. While the method contemplates releasing the implant after ithas been inserted, FIG. 34 shows an exploded view for the sake ofclarity. Once the implant is inserted, however, the surgeon may imagethe treated area to determine the position of the prosthetic disc. Theprosthetic disc assembly may have positioning aids to help a surgeondetermine whether the disc is in the proper position within theintervertebral space.

As seen in FIG. 34, implant holder 378 has a handle portion 388 andshaft portion 390. Handle portion 388 is designed for a surgeon to graspand as discussed previously may be configured with flat face 386. Shaftportion 390 houses two elongate rods 392, 394 that extend generally thelength of shaft portion 390. Rods 392,394 have threaded ends that mayextend beyond shaft 390. Threaded ends 396,398 are designed to engageinteriorly threaded bore holes 400,402 that reside on prosthetic disc380. In this fashion, prosthetic disc 380 may be releasably attached toimplant holder 378. Each rod 392,394 of shall 390 may be attached to awheel. As seen in FIG. 34, wheels 404,406 are attached to rods 394, 392,respectively. Accordingly, as wheels 404,406 are rotated so are rods394,392. In this fashion, a surgeon may actuate the elongate rods andtheir respective threaded ends to engage the interiorly threaded boreholes on the prosthetic disc.

With reference to FIG. 35, part of implant holder 378 is shown in across section view. As seen if FIG. 35, wheels 404,406 may be attachedto rods 392,394 by screws 408,410. With reference to FIG. 36, elongaterods 392,394 may extend into shaft portion 390, but shaft portion 390 isconfigured to leave spaces 412,414. This configuration allows rods 392,394 to translate by a small amount, which improves the threadingengagement of threaded ends 396,398 onto bore holes of the prostheticdisc. Because each rod 392,394 is allowed to translate independent ofthe other, threaded engagement of threaded ends 396,398 into bore holes400,402 is improved. In alternative embodiments, springs may be providedto tension rods 392, 394. In this fashion, threaded ends 396,398 aretensioned, which eases engagement of the rods when the prosthetic discis seated to the implant holder. As one of skill in the art wouldunderstand, independent tensioning of the rods allows a user to seat theprosthetic disc assembly to the implant holder and then engage each rodto the implant's threaded bores. With reference to FIG. 37, implantholder 378 is shown attached to prosthetic disc 380. As seen in FIG. 37,threaded ends 396, 398 of rods 392, 394 are shown engaging bore holes400,402. As one of skill in the art would understand, any number ofdifferent mechanisms may be employed to attach the implant to theimplant holder.

With reference to FIG. 38, the prosthetic disc is shown inserted intothe intervertebral space in its final position. As seen in FIG. 38, theprosthetic disc is placed into the intervertebral space via atransforaminal approach, i.e. at an angle oblique to the medial-lateralaxis. Accordingly, the methods and apparatus presented herein allow asurgeon to insert prosthetic discs into the intervertebral space via atransforaminal approach.

While it is apparent that the invention disclosed herein is wellcalculated to fulfill the objects stated above, it will be appreciatedthat numerous modifications and embodiments may be devised by thoseskilled in the art. Therefore, it is intended that the appended claimscover all such modifications and embodiments that fall within the truespirit and scope of the present invention.

1. A method of inserting an intervertebral prosthetic disc assembly froma transforaminal approach comprising: inserting a separator into theintervertebral space at an oblique angle from the medial lateral axis;inserting a trial into an intervertebral space at an oblique angle fromthe medial lateral axis; creating at least one first pathway in at leastone vertebral body with a chisel, wherein the location of said pathwayis determined by the position of the trial; inserting a prosthetic discassembly into an intervertebral space using at, least one first pathway,wherein at least one first pathway determines the position of the firstassembly wherein the prosthetic disc assembly having an upper endplatewith an extension portion and a lower endplate having first and secondside rails positioned along and above the length of the lower endplateand defining a first and second window on opposing sides of the lowerendplate, wherein the extension portion of the upper endplatesubstantially contacts an upper surface of the lower endplate andwherein the first and second side rails are curved to match thecurvature of the upper surface of the lower endplate thereby creatingthe first and second windows having an upper border that is defined bythe curved rails and a lower border that is defined by the curvature ofthe lower endplate.
 2. The method of claim 1, wherein the intervertebralprosthetic disc assembly comprises at least one keel.
 3. The method ofclaim 2, wherein the at least one keel rides within the at least onefirst pathway when the prosthetic disc assembly is implanted.
 4. Themethod of claim 1, wherein a complete or unilateral facetectomy isperformed.
 5. The method of claim 1, wherein a partial facetectomy isperformed.
 6. The method of claim 1, wherein the separator is a dilator.7. The method of claim 1, wherein the separator is a distractor.
 8. Themethod of claim 1, wherein the separator is both a dilator anddistractor.
 9. A method of inserting an intervertebral prosthetic discassembly from a transforaminal approach comprising: inserting aseparator into the intervertebral space at an oblique angle from themedial lateral axis; inserting a trial into an intervertebral space atan oblique angle from the medial lateral axis; creating at least onefirst pathway in at least one vertebral body with a chisel, wherein thelocation of said pathway is determined by the position of the trial;inserting a prosthetic disc assembly into an intervertebral space usingat least one first pathway, wherein at least one first pathwaydetermines the position of the first assembly wherein the prostheticdisc assembly having an upper endplate with an extension portion and alower endplate having first and second side rails positioned along andabove the length of the lower endplate and defining a first and secondwindow on opposing sides of the lower endplate, wherein the extensionportion is constrained within the first and second windows of the lowerendplate.
 10. The method of claim 9, wherein the intervertebralprosthetic disc assembly comprises at least one keel.
 11. The method ofclaim 10, wherein the at least one keel rides within the at least onefirst pathway when the prosthetic disc assembly is implanted.
 12. Themethod of claim 9, wherein a complete or unilateral facetectomy isperformed.
 13. The method of claim 9, wherein a partial facetectomy isperformed.
 14. The method of claim 9, wherein the separator is adilator.
 15. The method of claim 9, wherein the separator is adistractor.
 16. The method of claim 9, wherein the separator is both adilator and distractor.